Label: information for the patient

Onglyza 2.5mg film-coated tablets

saxagliptina

Read this label carefully before starting to take this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section4.

1.What is Onglyza and how is it used

2.What you need to know before starting to take Onglyza

3.How to take Onglyza

4.Possible adverse effects

5.Storage of Onglyza

6.Contents of the package and additional information

Onglyza contains an active ingredient called saxagliptin that belongs to a group of medications known as “oral antidiabetic drugs”. They act by helping to control the level of sugar in your blood.

Onglyza is used to treat adult patients aged 18 years or older with “type 2 diabetes”, if the disease cannot be adequately controlled with an oral antidiabetic medication, diet, and exercise. Onglyza is used alone or in combination with insulin or other antidiabetic medications.

It is essential that you follow the dietary and exercise advice provided by your doctor or healthcare professional.

Do not take Onglyza

• if you are allergic to saxagliptin or any of the other ingredients in this medication (listed in section6).
• if you have had a severe allergic reaction to any other medication similar to Onglyza that you take to control blood sugar levels. See section4.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Onglyza:

• if you are taking insulin. Onglyza should not be used in place of insulin;
• if you have type1 diabetes (your body does not produce insulin) or diabetic ketoacidosis (a complication of diabetes with high blood sugar levels, rapid weight loss, nausea, or vomiting). Onglyza should not be used to treat these medical conditions;
• if you have or have had a pancreatic disease;
• if you are taking insulin or a diabetes medication known as a “sulfonilurea”, your doctor may want to reduce your dose of insulin or sulfonilurea when taking either of them with Onglyza to avoid low blood sugar levels;
• if you have a condition that weakens your immune system, such as HIV/AIDS or medications you may take after an organ transplant;
• if you have heart failure or have other risk factors for developing heart failure, such as kidney problems. Your doctor will inform you about the signs and symptoms of heart failure. You should contact your doctor, pharmacist, or nurse immediately if you experience any of these symptoms. Symptoms may include, but are not limited to, a growing feeling of lack of air, rapid weight gain, and swelling of the feet (edema maleolar);
• if you have reduced kidney function, your doctor will decide if you need to take a lower dose of Onglyza. If you are on dialysis, then Onglyza is not recommended for you;
• if you have moderate or severe liver problems. If you have severe liver problems, it is recommended that you do not use Onglyza.

Diabetic skin lesions are a common complication of diabetes. Skin rash has been observed with Onglyza (see section4) and with certain diabetes medications in the same class as Onglyza. You are advised to follow the skin and foot care recommendations indicated by your doctor or healthcare professional.Contact your doctor if you find blisters on your skin, as it may be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop taking Onglyza.

Children and adolescents

Onglyza is not recommended for children and adolescents under 18years of age.

Other medications and Onglyza

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

In particular, you should inform your doctor if you are using medications that contain any of the following active ingredients:

• Carbamazepine, phenobarbital, or phenytoin. These may be used to control epilepsy (seizures) or chronic pain.
• Dexamethasone – a steroid medication. It may be used to treat inflammation in different parts of the body and organs.
• Rifampicin. This is an antibiotic used to treat infections such as tuberculosis.
• Ketoconazole. It may be used to treat fungal infections.
• Diltiazem. This is a medication used to lower blood pressure.

Pregnancy and breastfeeding

Consult your doctor before taking Onglyza if you are pregnant or planning to become pregnant. Do not use Onglyza if you are pregnant.

Consult your doctor if you want to breastfeed while taking this medication. It is unknown if Onglyza passes into human breast milk. Do not take this medication if you are breastfeeding or planning to breastfeed.

Driving and operating machinery

If you feel dizzy while taking Onglyza, do not drive or operate tools or machinery. Low blood sugar may affect your ability to drive and use machinery or work with firm support, and there is a risk of low blood sugar when taking this medication in combination with medications known to cause low blood sugar, such as insulin or sulfonylureas.

Onglyza contains lactose

The tablets contain lactose (milk sugar). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Onglyza contains sodium

This medication contains less than 1mmol of sodium (23mg) per dose; this is essentially “sodium-free”.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is 5mg once a day.

If you have reduced kidney function, your doctor may prescribe a lower dose. This is a 2.5mg tablet once a day.

Your doctor may prescribe Onglyza alone or with insulin or other diabetes medications. If so, remember to take these other medications as directed by your doctor for the best results for your health.

How to Take Onglyza

Tablets should not be divided or cut. Swallow the tablet whole with a little water. You can take the tablet with or without food. The tablet can be taken at any time of the day, but try to take the tablet at the same time every day to help you remember.

If You Take More Onglyza Than You Should

If you take more tablets than you should, consult a doctor immediately.

If You Forget to Take Onglyza

• If you forget to take a dose of Onglyza, take it as soon as you remember. However, if it is almost time for your next dose, do not take the missed dose.
• Do not take a double dose to make up for the missed dose. Never take two doses at the same time.

If You Stop Taking Onglyza

Continue taking Onglyza until your doctor tells you to stop. This will help you maintain controlled blood sugar levels.

If you have any other questions about using this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Some symptoms need immediate medical attention:

You should stop taking Onglyza and see your doctor immediately if you experience the following symptoms of low blood sugar: shakiness, sweating, anxiety, blurred vision, tingling in the lips, paleness, mood changes, disorientation, or confusion (hypoglycemia); observed very frequently (may affect more than 1 in 10 patients).

The symptoms of a severe allergic reaction (observed rarely, may affect up to 1 in 1,000 patients)may include:

• skin rash.
• Red, raised patches on the skin (hives).
• Swelling of the face, lips, tongue, and throat that may cause difficulty breathing or swallowing.

If you experience any of these symptoms, stop taking Onglyza and contact your doctor or nurse immediately. Your doctor may prescribe a medication to treat your allergic reaction and a different medication for your diabetes.

You should stop taking Onglyza and contact your doctor immediately if you notice any of the following severe side effects:

• Severe and persistent abdominal pain (in the stomach area) that may radiate to the back, as well as nausea and vomiting, which could be a sign of pancreatitis.

You should contact your doctor if you experience the following side effect:

• Severe joint pain.

Some patients have experienced the following side effects while taking Onglyza and metformin:

• Frequent (may affect 1 to 10 in 100 patients): chest or lung infection, urinary tract infection, inflammation of the stomach or intestines normally caused by an infection (gastroenteritis), sinusitis, inflammation of the nose or throat (nasopharyngitis) (the signs of this may include a cold or sore throat), headache, muscle pain (myalgia), vomiting, stomach inflammation (gastritis), stomach pain, and indigestion (dyspepsia).

• Rare (may affect 1 to 10 in 1,000 patients): joint pain (arthralgia) and difficulty achieving or maintaining an erection (erectile dysfunction).

Some patients have experienced the following side effects while taking Onglyza and a sulfonylurea:

• Very frequent: low blood sugar (hypoglycemia).
• Frequent: chest or lung infection, urinary tract infection, inflammation of the stomach or intestines, normally caused by an infection (gastroenteritis), sinusitis, headache, stomach pain, and vomiting.

• Rare: fatigue, abnormal lipid levels (fats) (dyslipidemia, hypertriglyceridemia).

Some patients have experienced the following side effects while taking Onglyza and a thiazolidinedione:

• Frequent: chest or lung infection, urinary tract infection, inflammation of the stomach or intestines, normally caused by an infection (gastroenteritis), sinusitis, headache, vomiting, stomach pain, and peripheral edema (swelling of the hands, ankles, or feet).

Some patients have experienced the following side effects while taking Onglyza and metformin and a sulfonylurea:

• Frequent: dizziness, fatigue, stomach pain, and flatulence.

Some patients have experienced the following additional side effects while taking Onglyza alone:

• Frequent: dizziness, diarrhea, and stomach pain.

Some patients have experienced the following side effects while taking Onglyza alone or in combination:

• Unknown frequency (frequency cannot be estimated from available data): constipation, appearance of blisters on the skin (pemphigoid bullous).

Some patients have experienced a small reduction in the number of a type of white blood cell (lymphocytes) detected through blood tests while taking Onglyza alone or in combination.

Reporting of side effects

If you experienceany type of side effect, consult your doctor, pharmacist, or nurse, even if it is apossibleside effect that does not appear in this leaflet.You can also report them directly through thenational reporting system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and on the packaging after EXP/CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Do not use this medication if the packaging is damaged or shows signs of tampering.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications you no longer need. In this way, you will help protect the environment.

Composition of Onglyza

• The active ingredient is saxagliptin. Each film-coated tablet contains 2.5 mg of saxagliptin (as hydrochloride).

• The other components are:

• Tablet core: lactose monohydrate; microcrystalline cellulose (E460i); sodium croscarmellose (E468); magnesium stearate.
• Film coating: polyvinyl alcohol; macrogol 3350; titanium dioxide (E171); talc (E553b) and yellow iron oxide (E172).
• Printing ink: shellac; aluminium lake carmine indigo (E132).

Appearance of the product and contents of the pack

• The 2.5 mg film-coated tablets are pale yellow to yellowish, biconvex, round. They have “2.5” printed on one face and “4214” printed on the other in blue ink.
• The tablets are presented in aluminium blisters.
• The 2.5 mg tablets are available in pack sizes of 14, 28 or 98 film-coated tablets in calendar blisters not pre-cut and 30x1 or 90x1 film-coated tablets in pre-cut single-dose blisters.

Only some pack sizes may be marketed in your country.

Marketing Authorisation Holder

AstraZeneca AB

SE-151 85 Södertälje

Sweden

Responsible for manufacturing

AstraZeneca AB

Gärtunavägen

SE‑152 57 Södertälje

Sweden

AstraZeneca UK Limited

Silk Road Business Park

Macclesfield

Cheshire

SK10 2NA

United Kingdom

For further information about this medicinal product, please consult the representative of the marketing authorisation holder in your country:

Last update of the summary of product characteristics:

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.